Telix Requested FDA for NDA Meeting; Added 2 New Partners in the US

  • May 28, 2019 AEST
  • Team Kalkine
Telix Requested FDA for NDA Meeting; Added 2 New Partners in the US

Telix Pharmaceuticals Limited (ASX: TLX) is a global biopharmaceutical company based in Melbourne. The company develops diagnostic and therapeutic products. Its focus is on radiopharmaceuticals or molecularly targeted radiation. TLX globally operates in regions like Kyoto, Brussels and Indianapolis. Currently, the company is working on a portfolio related to clinical-stage oncology products. The aim of this is to meet the medical requisites of renal, prostate and brain cancer.

Commercial partnerships of TLX (Source: Company’s report)

TLX provided a couple of updates on 28th May 2019 which are as follows:

The company had submitted a request to the FDA (United States Food and Drug Administration) to conduct a pre-NDA (New Drug Application) meeting. Ideally, the NDA is a procedure through which a company applies for marketing approval for a pharmaceutical product in the US region.

The above-mentioned request by the company is for the marketing authorization for the illumetTM, which is a prostate cancer imaging product, in the United States. Prior to this request, TLX had submitted a Drug Master File in July 2018. Various Investigational New Drug applications had followed it in the USA and Europe region. These were inclusive of Endocyte (now Novartis) VISION Phase III trial and other academic studies, building clinical experience and seeking new application areas for illumetTM.

TLX has a ready comprehensive pre-NDA package and it hopes to meet the FDA in July this year. This would conclude the go/no-go status of the submission to gain marketing authorization in the United States region.

Multiple Milestones and Readouts in 2019 (Source: Company’s report)

Further, the company mentioned that it has two new partners in its kitty for the US region. These are the UPPI (United Pharmacy Partners Inc.) and PharmaLogic. This addition rounds off the company’s product distribution network towards full commercialisation.

The company’s present distribution partner, Cardinal Health, had extended the partnering choices for TLX to optimally maximise its product distribution reach in the United States. However, this would be subject to marketing authorization (subject to FDA approval).

Also, the company’s distribution agreement with UPPI is for the illumetTM product. UPPI, along with its network of nuclear pharmacies, offers national coverage across regional cancer centres and the large Group Purchasing Organizations. PharmaLogic, the other new partner of the company, is a predominant player in the Western US. Pharmalogic, a chain of radiopharmacies and nuclear medicine imaging services.

Further, the Company’s President, Dr. Bernard Lambert said that TLX is making significant progress with the development of illumetTM. The company’s commercial platforms are also being built, and their reach is being extended to the US market, given in the recently announced partnerships.

On 22nd May 2019, the company released an excerpt from its CEO and Chairman address delivered at the company’s Annual General Meeting. In the past year, TLX underwent notable growth. Presently, it is active in 17 countries with 8 ongoing trails. It had acquired Atlab Pharma SAS and Advanced Nuclear Medicine Ingredients SA.

Share Price Information:

The market cap of the company is A$198.71 million. The stock of the company was trading at A$0.920, marginally up by 1.099% (as on 28 May 2019, AEST 3:15 PM. In the past year, the stock has delivered a return of 44.44%. The YTD return of the stock stands at 40.00%.


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